Objective: The authors investigated the effect of therapy with infliximab combined with methothrexate (MTX) in patients with rheumatoid arthritis (RA). They evaluated the effectiveness of treatment and the incidence of undesirable effects. Method: In the trial 37 patients were enrolled with an inadequate effect of hitherto applied MTX therapy. Infliximab was administered by the i.v. route, 3 mg/kg as follows: week 0-2-6, and subsequently every 8 weeks combined with oral MTX. Selected parameters were evaluated: the mean corticosteroid and MTX dose at the onset and at the end of treatment, the drop of NSA consumption, morning stiffness at the onset and at the end of therapy, the rate of onset of the therapeutic effect, evaluation of the therapeutic effect by the patient and doctor according to Likert’s scale, changes of ESR and CRP, incidence of side effects and premature termination of treatment. Evaluation of the investigated parameters was made at the onset and at the end of treatment with infliximab, laboratory parameters were evaluated after each administration of the drug. Results: After treatment a significant decline of the daily corticosteroid dose was recorded, reduction of the consumption of non-steroidal antirheumatics, a statistically significant reduction of the duration of morning stiffness and decline of the erythrocyte sedimentation rate and the CRP value (p < 0.001). The mean MTX dose did not change significantly. A positive effect of treatment was recorded in 97% patients, incl. an excellent and very good effect in 83% (evaluated by physician), and in 75% resp. (evaluated by patients). Side effects occurred in 14 patients (37.8%) incl. 4 cases (10.8%) with a medium severity allergic reaction, in 5 patients (13.5%) with an infection of the upper airways and in one case each with a urinary infection, bronchopneumonia, skin exanthema, chills and lympadenopathy. Therapy was terminated prematurely in 7 patients (18.9%) incl. 6 on account of side effects (16.2%). Conclusion: The investigation confirmed the favourable effect of treatment with infliximab combined with MTX in patients with active RA. Side effects of treatment included in particular uncomplicated infections and allergic reactions, other side effects were minimal. There was no case of tuberculosis.

        Key words: rheumatoid arthritis, therapy, infliximab, methotrexate, side effects